- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07639554
Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners (OPTIDEC COLO)
Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners: A Randomized Controlled Cluster Trial
The goal of this randomized trial is to assess the effectiveness of a targeted telephone reminder strategy, implemented by the patient's general practitioner, in enhancing participation in colorectal cancer screening among individuals who are not up to date . The participants are patients between 50 to 74 years old as they are the target for colorectal cancer screening. The main questions are:
- What is the percentage of patients who completed the colorectal cancer screening test during the intervention year , within the patient population of general practitioners participating in the study and identified as non-up-to-date for their screening status ?
- Identifying potential factors influencing the effectiveness of the intervention based on various characteristics of the patient, the geographical area, the general practitioner, and the caller
Researchers will compare with other patients who are not up to date without the intervention of their general practionner with a telephone reminder.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: José-philippe MORENO, MD
- Numero di telefono: +33686663181
- Email: jose_philippe.moreno@univ-fcomte.fr
Luoghi di studio
-
-
Franche-comté
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Champlitte, Franche-comté, Francia
- MSPU des 3 provinces
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Investigatore principale:
- José-Philippe MORENO, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria for general practionners :
- Practise in one of the four departments of the Franche-Comté region; ractise in a solo practice, group practice, multidisciplinary primary care centre , or community health centre;
- Are engaged in general medical practice.
- Have agreed to participate in the study.
Inclusion Criteria for patients :
- patients within the practice population of general practitioners selected to participate in the study;
- aged between 50 and 75 years inclusive;
- affiliated with the French general health insurance scheme or the agricultural social insurance scheme
Exclusion Criteria for general practionners:
- practise exclusively in a specialty other than general practice (e.g. osteopathy, allergology, vascular medicine).
Non inclusion Criteria for patients :
- Objection expressed by the patient to the change in the purpose of data processing for research purposes
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervention Arm : phone-based outreach to promote colorectal cancer screening
In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening.
Each patient's screening status will be verified by the clinical research associate through a review of the medical records.
A telephone call will be made by a member of the patient's primary care team.
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A telephone call will be made by a member of the patient's primary care team (general practitioner, medical secretary, public health nurse, or care coordinator), with priority given to a call by the patient's general practitioner.
The call should preferably be made to the patient's mobile phone.
If the call is unsuccessful, a voicemail message will be left, and a second call will be attempted within the following seven days.
The voicemail message will include the name of the patient's general practitioner, the purpose of the call regarding colorectal cancer screening, and notification that a further attempt will be made to reach the patient.
If the telephone exchange is successful, an appointment at the healthcare facility will be offered to the patient, during which the screening test will be offered to the patient, during which the screening test will be handed over and explained by one of the healthcare professionals from the same facility.
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Nessun intervento: Control arm
In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening.
Each patient's screening status will be verified by the clinical research associate through a review of the medical records.
There will not be an intervention.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of patients who completed the colorectal cancer screening in each arms
Lasso di tempo: 6 months after inclusion
|
Patients who completed the colorectal cancer screening test during the intervention year (year n), within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening - a status that was confirmed by reviewing their medical records. Completion of the screening will be confirmed by the presence of the test result in the patient's medical record within the General practionner's practice software, no later than three months after the end of the intervention. This mesure will be done in each arm. |
6 months after inclusion
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database
Lasso di tempo: 1 year after enrollment
|
Patients whose colorectal cancer screening status changed between the list received from National Health in year n and the list received in year n+1. A change in status will be confirmed by the absence of the patient from the n+1 list, among those still registered within the general practitioner's patient panel. |
1 year after enrollment
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Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables
Lasso di tempo: 3 months after the end of enrollment
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Patients who completed the colorectal cancer screening (CRC) test during the intervention year , within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening. This proportion will be analysed according to the following stratification variables:
|
3 months after the end of enrollment
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Number of participants per stage of the intervention process
Lasso di tempo: 3 months after the end of enrollment
|
In both study arms, identification of patients incorrectly included in the national health insurance list (i.e. patients already up to date with screening, those excluded from CRC screening, those under or awaiting colonoscopic follow-up, or currently undergoing treatment for colorectal cancer). For the intervention arm, classification of all patients according to the following outcomes:
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3 months after the end of enrollment
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quantifying the time required to carry out the intervention
Lasso di tempo: 3 months after the end of the enrollment
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In the intervention arm, time spent on all stages of the intervention:
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3 months after the end of the enrollment
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-A01370-49
Informazioni su farmaci e dispositivi, documenti di studio
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